Amarin Corp Plc (AMRN)

[mc1988]

The examiner did examine Kurabayashi though, based on the Non-Patent Citations section of the patents that cite Kurabayashi.

Even if we assume that the Patent Office did not examine Kurabayashi, it is an error to claim that Kurabayashi showed EPA reduced Apo-B because while EPA does reduce Apo-B in a statistically significant manner over time, there is no statistically significant change in Apo-B levels when it is compared to the control group. The statistically significant change in Apo-B in the EPA group over time is better interpreted as a measurement artifact (in my opinion).

Page 523 of Kurabayashi:

The changes in serum levels of apolipoproteins from baseline to week 48 are shown in Table 3. The apolipoprotein A-II level in the eicosapentaenoic acid group significantly decreased from baseline to week 48, and there were significant differences between the two groups at weeks 12 and 24. The apolipoprotein B level in the eicosapentaenoic acid group was significantly lower at week 48 compared with the baseline level, but there was no significant difference between the groups. The atherosclerotic index of the eicosapentaenoic acid group decreased significantly from baseline to week 48. In the eicosapentaenoic acid group, the level of lipopro- tein(a) significantly decreased from baseline to week 48. The difference in remnant lipoprotein cholesterol was not statistically significant.

(Copy of Kurabayashi here https://sci-hub.tw/https://www.sciencedirect.com/science/article/pii/S0029784400009881)

Furthermore, for the legal case in particular, the burden of proof should be on the defendant to prove that the patent examiner is incorrect. It should not be on Amarin (or us) to show that the defendant is wrong.